FDA.reportPublic FDA data

ENSULIZOLE, OCTISALATE

Manufacturer
Parfums Christian Dior
Effective date
2023-11-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:49

Label at a glance#

ProductCAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1N
Active ingredientENSULIZOLE, OCTISALATE
Label structure8 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun.  see Directions

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures. limit time in the sun, especially fro...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ensulizole 2.70 % Octisalate 4.50 %

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun.  see Directions

Warnings

WARNINGS SECTION

For external use only.

Do not use 

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product,

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

• AQUA (WATER) • DIMETHICONE • METHYL TRIMETHICONE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • PHENYL TRIMETHICONE • SYNTHETIC FLUOROPHLOGOPITE • GLYCERIN • PENTYLENE GLYCOL • SILICA • BUTYLENE GLYCOL• SORBITAN SESQUIOLEATE • TROMETHAMINE • ACRYLATES/DIMETHICONE COPOLYMER • MICA • DIMETHICONOL • PARFUM (FRAGRANCE) • SODIUM MYRISTOYL GLUTAMAT • GLYCERYL UNDECYL DIMETHICONE • CHLORPHENESIN • CAPRYLYL GLYCOL• SODIUM CHLORIDE • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • POLYSORBATE 80 • HYDROGEN DIMETHICONE • ALUMINUM HYDROXIDE • ADENOSINE• SODIUM ACETYLATED HYALURONATE • XYLITOL • TOCOPHEROL • SODIUM SURFACTIN • AFRAMOMUM ANGUSTIFOLIUM SEED EXTRACT • PALMARIA PALMATA EXTRACT • SODIUM BENZOATE • HYDROLYZED SOY PROTEIN • PAEONIA LACTIFLORA ROOT EXTRACT • TREHALOSE • POTASSIUM SORBATE • LILIUM CANDIDUM BULB EXTRACT • JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT. [MAY CONTAIN:CI 77491,CI 77492,CI 77499 (IRON OXIDES) • CI 77891 (TITANIUM DIOXIDE) • CI 77947 (ZINC OXIDE)].
N°15310/Z

Package Labeling:61957-2401-0

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inner Package2Inner Package2Outer Package2Outer Package2Label2Label2

Package Labeling:61957-2401-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TESTER3TESTER3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61957-2401-0CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1N30 mL in 1 BOTTLEEMULSION303
61957-2401-1CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1N20 mL in 1 TUBEEMULSION203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61957-2401CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1N (ENSULIZOLE, OCTISALATE) EMULSION [PARFUMS CHRISTIAN DIOR]3Current NDC, Legacy NDC, 2 package rows20231104_d2ca01ad-68b2-4312-a9d0-04d3e992bb13.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61957-240161957-2401-0, 61957-2401-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
TROMETHAMINE023C2WHX2VIACT
MICAV8A1AW0880IACT
DIMETHICONOL (100000 CST)OSA9UP217SIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
CHLORPHENESINI670DAL4SZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
POLYSORBATE 806OZP39ZG8HIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ADENOSINEK72T3FS567IACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
XYLITOLVCQ006KQ1EIACT
TOCOPHEROLR0ZB2556P8IACT
AFRAMOMUM ANGUSTIFOLIUM SEEDOSF83Q896JIACT
PALMARIA PALMATA7832HOY4ZQIACT
SODIUM BENZOATEOJ245FE5EUIACT
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
PAEONIA LACTIFLORA ROOT3Z3866YW6PIACT
TREHALOSEB8WCK70T7IIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
LILIUM CANDIDUM BULBAHG15J8AM0IACT
JASMINUM OFFICINALE FLOWER0Q8K841432IACT
ENSULIZOLE9YQ9DI1W42ACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1NENSULIZOLE, OCTISALATEParfums Christian Diord2ca01ad-68b2-4312-a9d0-04d3e992bb132023-11-03WarningsExact identifier
ndc (package): 61957-2401-0
ndc (package): 61957-2401-1
ndc (product): 61957-2401
ndc11 (package): 61957240101
ndc11 (package): 61957240100
spl id: 094a99da-2067-0836-e063-6394a90a0233
spl set id: d2ca01ad-68b2-4312-a9d0-04d3e992bb13

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.